Regulatory

FDA OKs Schering-Plough's Peg-Intron pen injector

Last Updated: 2003-10-13 16:12:25 -0400 (Reuters Health)

By Toni Clarke

NEW YORK (Reuters) - Schering-Plough Corp. said on Monday it won U.S. regulatory approval to sell its Peg-Intron hepatitis C drug in a pre-filled injector "pen," potentially staving off further erosion of its market share by a rival product from Roche Holding AG.

The device, called Redipen, is designed to be simpler to use than the current method of administering the drug, in which patients must use two syringes and two vials in a process that combines a liquid and a powder.

"It is extremely important for Schering-Plough to defend Peg-Intron, as the entire franchise now represents between 15 and 20 percent of total sales," said Brian Lester, an analyst at Manning & Napier Advisors Inc.

Switzerland's Roche has made inroads by convincing doctors that its Pegasys drug is just as effective as Peg-Intron but much more convenient to administer. Not only does the drug come in a pre-filled device, the dose is not dependent on a patient's weight.

Redipen removes at least some of those advantages. It is a disposable, single-dose device in which the Peg-Intron powder is mixed with sterile water. The dose is dependent on weight, however. Patients select the dose applicable to their weight by turning a dial on the pen.

"Redipen does narrow the convenience issue that Pegasys has, so it should help Schering-Plough stem the market losses," said Lester. "But Schering-Plough is certainly not abandoning the weight-based dosing or deviating from its position that weight-based dosing confers superior efficacy."

Schering-Plough is in fact determined to prove its case. Last month the company said it plans to conduct a large clinical trial comparing Peg-Intron and Pegasys.

Pegasys and Peg-Intron are both combination therapies that include a long-acting interferon drug and the antiviral drug ribavirin.

Shares of Schering-Plough rose 19 cents, or 1.2 percent, to $16.25 in late-morning trading on the New York Stock Exchange.